DUBLIN, Feb. 25, 2017 /PRNewswire/ -- Endo
International plc (NASDAQ / TSX: ENDP) today announced that one of
its operating companies, Endo Pharmaceuticals Inc. based in
Malvern, Pennsylvania, is
voluntarily recalling one lot of Edex® (alprostadil for injection)
10 mcg to the consumer level. This product recall is due to the
detection by Endo of a defect in the crimp caps used in the
manufacture of the subject product lot.
This defect has the potential to lead to a loss of container
closure integrity, which could impact the product's sterility
assurance and may lead to serious adverse events such as
infections, both localized at the site of injection and
systemically. To date, Endo has not received adverse event reports
related to this recall.
Edex® (alprostadil for injection) is a prescription only
intracavernous injection indicated for the treatment of male
erectile dysfunction. The recall applies to the 10 mcg strength,
packaged in a 2 pack carton, (NDC 52244-010-02), product lot number
207386, Expiration Date: May 2019
(see photographs of packaged product within). The affected lot was
distributed from December 13, 2016
through February 13, 2017 to
wholesale distributors and retail pharmacies throughout
the United States. The lot number
can be found on the manufacturer's unit. Consumers who are unsure
if they have the affected lot number should consult their
pharmacist or health care professional.
Consumers in possession of any unused prescribed Edex® 10
mcg product bearing lot number 207386 should immediately
discontinue use of the product and return the unused product
by following the instructions below:
- Please contact Inmar at 1-844-529-1586, Monday through
Friday (9am to 5pm EST)
or email Edex@inmar.com for the
following:
- Product Return
- Upon contacting Inmar and indicating you have unused
product, please expect Return Authorization labels and Shipping
instructions.
- Product Reimbursement
- Upon contacting Inmar, please be prepared to share proof
of purchase.
- Proof of purchase can be sent to
Edex@inmar.com or 635 Vine St. Winston Salem, NC 27101-Attention Recall
Department, Edex Recall.
Pharmacists and wholesalers are asked to check their inventories
for lot number 207386, segregate any impacted inventory and contact
Inmar at extension #1 at 1-800-967-5952, Monday through Friday
(9 a.m. to 5 p.m. EST) or via e-mail
at rxrecalls@inmar.com for instructions on product
return. Pharmacists who have dispensed impacted product are asked
to notify their patients of this recall. Pharmacies and wholesalers
that received lot number 207386 will receive a letter as well as a
copy of this press release with their recall notification
information.
Endo takes this issue seriously and is fully committed to
ensuring all of its products and packaging meet the highest quality
standards. If you have any questions regarding this recall,
please call 1-800-462-ENDO (3636), between the hours of
8:00 a.m. to 8:00 p.m. EST Monday through
Thursday and 8:00 a.m. to 6:00 p.m.
EST on Friday. Consumers should contact their physician or
healthcare provider if they have experienced any problems that may
be related to using this product. Additional information regarding
this recall can be found at
http://www.endo.com/endopharma/our-products.
Adverse reactions or quality problems associated with the use of
this product may be reported to FDA's MedWatch Adverse Event
Reporting program either by phone, on line, by regular mail or by
fax.
- Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request
a reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178.
This Product Recall is being made with the knowledge of the
United States Food and Drug Administration (FDA).
About Endo International plc
Endo International plc
(NASDAQ / TSX: ENDP) is a highly focused generics and specialty
branded pharmaceutical company delivering high-quality medicines to
patients in need through excellence in development, manufacturing
and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
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